Medical Device Preemption Developments

Boring title, but accurate.  Here’s the latest.


First, Medtronic won another one the other day.  Duggan v. Medtronic, Inc., ___ F. Supp.2d ___, 2012 WL 45503 (D. Mass. Jan. 10, 2012), involved an insulin delivery system.  It had a number of components, including the pump, which physically moved the insulin from where it’s stored into the body.  Plaintiffs alleged that the pump malfunctioned and caused undisclosed injuries.

The insulin system was a PMA device, so the defendants moved for summary judgment on grounds of preemption.  Plaintiffs targeted the pump, rather than any other aspect of the system, because the pump had originally been §510k cleared (unpreempted under Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)) – by itself – in 2004.  The insulin delivery system predated the pump, and was PMA approved.  By PMA supplement in 2006, the FDA approved incorporation of the pump into the system.  The plaintiff was prescribed that system.  Duggan, 2012 WL 45503, at *3-4.

Plaintiffs’ primary argument for avoiding preemption was that the components in the system should be parsed, the 2006 PMA supplement ignored, and the pump treated as a “mere” §510k device.  They got nowhere.  The same argument had been made, and rejected, in other device system litigation (mostly knee implants, if we recall):

Many courts have held that once premarket approval is granted, all claims relating to all components of the device are preempted. This analysis applies even where a component of a PMA-approved device had previously been approved through the § 510(k) process.

Id. at *4 (citations omitted).

Plaintiffs then tried component part argument 2.0, claiming that the data in the defendant’s supplement was insufficient to support PMA approval of the pump.  Id. at *5.  The opinion doesn’t detail the basis of that argument, but we assume that some malleable FDA “expert” was involved.  The court refused to allow PMA preemption turn on a litigant’s after-the-fact deconstruction of the approval submission.  What the FDA decided, not what a litigant claimed that the FDA should have decided, controlled:

[T]he sufficiency of the data submitted to the FDA with respect to the safety and efficacy of a device does not govern the scope of the premarket approval.  Whether a product is FDA-approved is determined by the language in the approval letter, not by the application documents submitted to it for review.  The FDA, not litigants, is entrusted with the responsibility to police the sufficiency of the evidence to support a PMA approval.

Duggan, 2012 WL 45503, at *5 (citing our old pal, Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001)).  We view this holding as the most important takeaway from Duggan.

Interestingly, plaintiffs also tried to intervene with the FDA itself, attempting to depose Agency personnel and filing an FDA citizen’s petition challenging the scope of the PMA.  2012 WL 45503, at *3.  Both moves backfired.  It’s really difficult to depose government personnel when the government doesn’t want it.  E.g., United States ex rel. Touhy v. Regan, 340 U.S. 462 (1951).  That goes double for the FDA in the First Circuit.  See Giza v. Secretary of HEW, 628 F.2d 748 (1st Cir. 1980).  Oops.  Duggan, 2012 WL 45503, at *5 (plaintiffs forced to drop subpoena).  On top of that, the FDA denied the petition, reaffirming that the PMA covered the entire system.  Really oops.  Id. (“[t]o the extent there was any ambiguity about the scope of the approval letter, this rejection of the Citizen Petition is the cherry on the icing”).  Observing that plaintiffs had thusly shot themselves in the foot, the court granted summary judgment.  Id.

Second, Boston Scientific won a preemption motion in a rather unusual case in Erickson v. Boston Scientific Corp., No. SACV 10-698 AG (ANx), slip op. (C.D. Cal. Dec. 12, 2011).  We’re only just finding out about it, though.  The unusual nature of the case is the general attack on the life expectancy of several of the defendant’s products (pacemakers powered by batteries).  The plaintiff claimed that he had been told that four different pacemakers “would last ten years” but that none of them (except the last, which hadn't been implanted very long) came close to that lifespan.  Slip op. at 2.

Erickson was dismissed via judgment on the pleadings.  So, initially, it is a valuable judicial notice decision, as the court took judicial notice of the FDA approvals of all four pacemakers (six total FDA documents) – a PMA, two PMA supplements, and several supplemental product development protocols (“PDPs”).  Slip op. at 3-4.  Judicial notice, of course, allows for dismissal on the pleadings, thereby saving considerable discovery expense and reducing the nuisance value of plainly preempted litigation.

Erickson held that both of these regulatory avenues – the PMA supplements and supplemental PDPs – were equivalent to pre-market approval, and thus preemption under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), barred the action.   Slip op. at 7.  The decision discussed supplemental PDPs at some length:

Some of Defendants’ pacemakers were not subject to the FDA’s PMA process, but were instead approved through the FDA’s supplemental Product Development Protocol (“PDP”).  In Reigel, the Supreme Court stated that an application for supplemental premarket approval is “evaluated under largely the same criteria as an initial application.”  Riegel v. Medtronic, Inc., 552 U.S. 312, 319.  Courts have interpreted Reigel to mean that preemption applies equally to both the PMA and PDP processes.

Slip op. at 8 (other citations omitted).  We’ve seen supplemental PMA and PDP preemption decisions before (see our device preemption scorecard for details), but Erickson is the first case we can recall specifically discussing a supplement to a PDP in the context of preemption.  That’s probably the most important takeaway from Erickson.

In Erickson the plaintiff also trotted out the “parallel violation” exception.  Slip op. at 9-10.  The defendant made mincemeat of it – aided significantly by the plaintiff's failure to plead anything resembling an adequate parallel claim.  Plaintiff did not allege what was violated or how that related to his claim.  Id. at 9-10. That didn’t cut it:

[A] plaintiff cannot simply incant the magic words “[defendant] violated FDA regulations” in order to avoid preemption.  Rather, a plaintiff must allege that the defendant violated a particular federal specification referring to the device at issue, or identify specific PMA requirements that have been violated.

Slip op. at 9 (citations and quotation marks omitted).

The only thing specific that the plaintiff in Erickson alleged was that some of the pacemakers had been recalled.  A bare allegation of a recall, however, wasn’t nearly enough.  First, “[m]any courts have recognized that product recalls do not create a presumption that FDA requirements have been violated.” Slip op. at 10 (citations omitted).  Second, recalls do not amount to withdrawal of approval.  Id. Third, the recall wasn't even relevant, since there was no allegation “that the recall was prompted by defects relating to the pacemakers’ longevity.”  Id.

The treatment of the recall is a second very usable takeaway from Erickson. Finally, for the record, Erickson also dismissed fraud claims as insufficiently pleaded, slip op. at 10-11, and throws out several of the claims (the older pacemakers) under the statute of limitations.  Id. at 13-15.

We Don't Recall

We’ve been around the preemption block a few times – we know what happens when the mainstay claim in prescription medical product liability litigation, that being inadequate warnings, gets preempted.

We first saw it in DTP vaccine litigation.  We made a little headway with preemption and plaintiffs responded with “design’ claims based on non-FDA-approved formulations.  It took the Vaccine Act to bury those.

We saw it again in Bone Screw litigation, pre-Lohr.  Plaintiffs responded with fraud on the FDA claims.  It took Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), to do those in.

We saw it yet again in prescription drug litigation, pre-Levine.  Plaintiffs responded with all manner of things – design defect claims with no alternative design at all, failure to test, illegal promotion, you name it. S ome of these we’re still fighting, but with the preemption threat to warning claims removed, most of these have receded into the background.

We saw – and see – it a fourth time in PMA medical devices, especially after Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  The plaintiff’s alternative has been disguised private FDCA enforcement actions presented as “parallel violation” claims.

And we expect to see it again now that PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), has knocked out warning claims in generic drug cases.  So what’s the non-traditional (a/k/a weird) claim of choice there going to be?  The jury’s still out on that, but judging from the Mensing reargument petition, which we discussed here, one oddball claim under serious consideration by the other side is the notion that a defendant can have a common-law obligation simply not to sell its product at all.

In other words, the flavor du jour in generic cases could be failure to recall, resurrected from what has to date been extensive and well-deserved judicial repudiation.

While we don’t represent generics (there’s a big legal divide between branded and generic manufacturers, that we need not go into), we don’t really want them to lose this battle either, because any weird claim that finds a foothold in generic litigation will eventually bleed over and be asserted against our clients, too.  So we thought we’d do a number on failure to recall/negligent recall in the hope of nipping this one in the bud.

Probably the best place to start when thinking about common-law claims that defendants should remove their (FDA-approved) products from the market entirely, or face universal liability simply for selling them, is with the Third Restatement of Torts.  In section 11 recall-related liability is recognized only in limited situations after a recall has already otherwise been instituted:

One engaged in the business of selling or otherwise distributing products is subject to liability for harm to persons or property caused by the seller's failure to recall a product after the time of sale or distribution if:

(a)(1) a governmental directive issued pursuant to a statute or administrative regulation specifically requires the seller or distributor to recall the product; or

(a)(2) the seller or distributor, in the absence of a recall requirement under Subsection (a)(1), undertakes to recall the product; and

(b) the seller or distributor fails to act as a reasonable person in recalling the product.

Restatement (Third) of Torts, Products Liability §11 (1998).

By implication, the black letter law of the Restatement rejects any common-law obligation to remove a product from the market ab initio (that’s how we lawyers say “in the first place”).  That implication is made explicit by the very first comment to Restatement §11.  One ground for not allowing plaintiffs to argue that products should be taken off the market altogether is that such after-the-fact recall duties would be excessively expensive:

Duties to recall products impose significant burdens on manufacturers. Many product lines are periodically redesigned so that they become safer over time.  If every improvement in product safety were to trigger a common-law duty to recall, manufacturers would face incalculable costs every time they sought to make their product lines better and safer.

Restatement (Third) of Torts, Products Liability §11, comment a (1998).  A second reason is that decisions about whether the public, as a whole, should be deprived of access to a product is not something properly left to judges and juries in common-law tort litigation:

[A]n involuntary duty to recall should be imposed on the seller only by a governmental directive issued pursuant to statute or regulation. Issues relating to product recalls are best evaluated by governmental agencies capable of gathering adequate data regarding the ramifications of such undertakings.

Id.

So that’s one.  But a restatement is supposed to restate the law, right?  Does this one?

You betcha.

In state after state, whether product liability is common-law or statutory, and whether it’s based on the Second or Third Restatement, courts have refused to allow plaintiffs to make claims asserting that legal products should not have been sold at all.  This precedent includes decades-old cases, e.g., Women’s Health Network, Inc. v. A. H. Robins Co., 545 F. Supp. 1177, 1181 (D. Mass. 1982) (“[n]o court has ever ordered a notification and recall campaign on the basis of state law”), and recent cases decided within the past year.  See Murray v. General Motors, 2011 WL 52559, at *2 (S.D. Miss. Jan. 7, 2011) (plaintiffs “cannot show that [defendant] breached its duty by not recalling their vehicle”).

While this precedent goes well beyond prescription drug and medical device cases, one of the best cases is from the same court that, long ago, invented strict liability.  In Ramirez v. Plough, Inc., 863 P.2d 167 (Cal. 1993), the California Supreme Court refused to order one of the first drugs ever – aspirin – off the market. There was no duty to recall aspirin because of Reyes syndrome:

The other alternative ground of liability is that defendant should not have marketed [aspirin] at all because the risks of Reye’s syndrome clearly outweighed any benefit to be derived from the product, particularly in light of the availability of non-aspirin pain relievers.  We conclude, however, as a matter of law, that defendant may not be held liable for failing to withdraw its product from the market. . . .  A few scientific studies had shown an association between [the product] and [the condition] but the methodology of those studies had been questioned and the FDA had determined that further studies were needed to confirm or disprove the association.  Pending completion of those studies, the FDA concluded that product warnings were an adequate public safety measure.  Although the FDA’s conclusion is not binding on us, we think it deserves serious consideration.

Id. at 177-78.

Another thorough treatment of the issue is in Ford Motor Co. v. Reese, 684 S.E.2d 279 (Ga. App. 2009), which we blogged about a couple of years ago.  Obviously, Reese involved a car rather than a drug, but the considerations weren’t much different from those in Ramirez.

We conclude that absent special circumstances, no common law duty exists under Georgia law requiring a manufacturer to recall a product after the product has left the manufacturer's control.  Under our products liability jurisprudence, a manufacturer’s duty to implement alternative safer designs is limited to the time the product is manufactured, not months or years later when technology or knowledge may have changed. . . .  [I]mportant public policy concerns support our decision not to impose a continuing duty to recall upon manufacturers.  Because the cost of locating, recalling, and replacing mass-marketed products can be enormous and will likely be passed on to consumers in the form of higher prices, the recall power should not be exercised without extensive consideration of its economic impact.  Courts, however, are constituted to define individual cases, and their inquiries are confined to the particular facts and arguments in the cases before them.  Decisions to expand a manufacturer's post-sale duty beyond making reasonable efforts to warn product users about newly discovered dangers should be left to administrative agencies, which are better able to weigh the costs and benefits of such action.

Id. at 284-85 (lots of citations and quotation marks omitted).

Courts in fully half the states in the country have considered whether to recognize a duty to recall this or that kind of product.  The sheer range of products against which recall claims have been asserted demonstrates how much of a change in the law this theory would represent if ever accepted.  So far, however, the courts have uniformly rejected failure to recall as a basis of product liability.  In the hope that they will continue to do so – when inveigled by generic plaintiffs looking for some non-preempted alternative – we provide this list, which we think is comprehensive:

• Alaska:  Nelson v. Original Smith & Wesson Business Entities, 2010 WL 7125186, at *3-4 (D. Alaska May 18, 2010), reconsideration denied, 2010 WL 7125187 (D. Alaska June 14, 2010) (firearm).


• California:  Ramirez, 863 P.2d at 177-78 (OTC aspirin).


• Delaware:  Smith v. Daimlerchrysler Corp., 2002 WL 31814534, at *6 (Del. Super. Nov. 20, 2002) (automobile).


• Florida:  Thomas v. Bombardier Recreational Products, Inc., 682 F. Supp.2d 1297, 1302 (M.D. Fla. 2010) (personal watercraft).


• Georgia:  Ford v. Reese, 684 S.E.2d at 283-85 (automobile); Yarbrough v. Actavis Totowa, LLC, 2010 WL 3604674, at *4 (S.D. Ga. Sep. 13, 2010) (Digitek).


• Hawaii:  Tabieros v. Clark Equipment Co., 944 P.2d 1279, 1301 (Hi. 1997) (marine cargo equipment).


• Illinois:  Rogers v. Clark Equipment Co., 744 N .E.2d 364, 370 (Ill. App. 2001) (forklift); Modelski v. Navistar International Transportation Corp., 707 N.E.2d 239, 247-48 (Ill. App. 1999) (tractor); Smith v. BOC Group PLC, 2001 WL 477237, at *5 (N.D. Ill. May 4, 2001) (ethylene oxide); Moorehead v. Clark Equipment Co., 1987 WL 26158, at *2-3 (N.D. Ill. Dec. 2, 1987) (forklift).


• Iowa:  Lovick v. Wil-Rich, 588 N.W.2d 688, 696 (Iowa 1999) (cultivator); Burke v. Deere & Co., 6 F.3d 497, 508 n.16 (8th Cir. 1993) (applying Iowa law) (combine).


• Kansas:  Patton v. Hutchinson Wil-Rich Manufacturing Co., 861 P.2d 1299, 1315 (Kan. 1993) (cultivator); Kinser v. Gehl Co., 184 F.3d 1259, 1270 (10th Cir. 1999) (applying Kansas law) (baler); Langehennig v. Sofamor, Inc., 1999 WL 1129683, at *8 (D. Kan. May 28, 1999) (bone screws).


• Kentucky:  Ostendorf v. Clark Equipment Co., 122 S.W.3d 530, 534 (Ky. 2003) (forklift).


• Massachusetts:  Women’s Health Network, 545 F. Supp. at 1181 (Dalkon shield).


• Michigan:  Gregory v. Cincinnati Inc., 538 N.W.2d 325, 333-34 (Mich. 1995) (press); Eschenburg v. Navistar International Transportation Corp., 829 F. Supp. 210, 214-15 (E.D. Mich. 1993) (combine).


• Minnesota:  Kladivo v. Sportsstuff, Inc., 2008 WL 4933951, at *5 (D. Minn. Sep. 2, 2008) (inflatable water tube); Hammes v. Yamaha Motor Corp., 2006 WL 1195907, at *11 (D. Minn. May 4, 2006) (motorcycle); Berczyk v. Emerson Tool Co., 291 F. Supp.2d 1004, 1016 (D. Minn. 2003) (power saw); McDaniel v. Bieffe USA, Inc., 35 F. Supp.2d 735, 743 (D. Minn. 1999) (motorcycle helmet).


• Mississippi:  Murray, 2011 WL 52559, at *2 (automobile).


• Missouri:  Horstmyer v. Black & Decker, (U.S.), Inc., 151 F.3d 765, 783-84 (8th Cir. 1998) (applying Missouri law) (power saw); Smith v. Firestone Tire & Rubber Co., 755 F.2d 129, 135 (8th Cir. 1985) (applying Missouri law) (tire); Stanger v. Smith & Nephew, Inc., 401 F. Supp.2d 974, 982 (D. Mo. 2005) (tibial implant); Efting v. Tokai Corp., 75 F. Supp.2d 1006, 1011 (W.D. Mo. 1999) (cigarette lighter); Davidson v. Besser Co., 70 F. Supp.2d 1020, 1027 (E.D. Mo. 1999) (concrete fabricator).


• New Jersey:  Leslie v. United States, 986 F. Supp. 900, 913 (D.N.J. 1997), aff’d mem., 178 F.3d 1279 (3d Cir. 1999) (hollow point bullets).


• New Mexico:  Morales v. E.D. Etnyre & Co., 382 F. Supp.2d 1285, 1287 (D.N.M. 2005).


• New York:  Adams v. Genie Industries, Inc., 929 N.E.2d 380, 385 (N.Y. 2010) (personal lift vehicle).


• North Dakota:  Eberts v. Kawasaki Motors Corp., U.S.A., 2004 WL 224683, at *2-3 (D.N.D. Feb. 2, 2004) (ATV).


• Pennsylvania:  Lance v. Wyeth, 4 A.3d 160, 167 (Pa. Super. 2010), appeal granted, 15 A.3d 429 (Pa. 2011) (diet drugs); Padilla v. Black & Decker Corp., 2005 WL 697479, at *7 (E.D. Pa. Mar. 24, 2005) (power saw); Boyer v. Case Corp., 1998 WL 205695, at *2 (E.D. Pa. Apr. 28, 1998) (forklift); Girard v. Allis Chalmers Corp., 787 F. Supp. 482, 486 n.3 (W.D. Pa. 1992) (bulldozer); Grant v. Bridgestone/Firestone, Inc., 55 Pa. D. & C.4th 438, 445-46 (Pa. C.P. 2001) (tire); Engle v. BT Industries AB, 41 Pa. D. & C.4th 25, 27 (Pa. C.P. 1999) (forklift).


• South Carolina:  Bragg v. Hi-Ranger, Inc., 462 S.E.2d 321, 331 (S.C. App. 1995) (aerial bucket truck).


• South Dakota:  Robinson v. Brandtjen & Kluge, Inc., 2006 WL 2796252, at *8 (D.S.D. Sept. 27, 2006), aff’d, 500 F.3d 691 (8th Cir. 2007) (printing press).


• Tennessee: Spence v. Miles Laboratories, Inc., 810 F. Supp. 952, 959 (E.D. Tenn. 1992) (blood clotting factor concentrate).


• Texas:  Syrie v. Knoll International, 748 F.2d 304, 311-12 (5th Cir. 1984) (applying Texas law) (stool); Guizhi v. Bell Helicopter Textron, Inc., 1997 WL 786494, at *3 n.4 (N.D. Tex. Dec. 16, 2009) (helicopter); Hernandez v. Ford Motor Co., 2005 WL 1574474, at *1 (S.D. Tex. June 28, 2005) (automobile); Flock v. Scripto-Tokai Corp., 2001 WL 34111725, at *8-9 (S.D. Tex. Sep. 11, 2001) (cigarette lighter).


• Washington:  Bear v. Ford Motor Co., 2007 WL 870344, at *3 (E.D. Wash. Mar. 20, 2007) (automobile).

Frankly, we think failure to recall claims, when brought against FDA-approved products, are absolutely preempted, since the conflict between the FDA saying yes, and a plaintiff saying no, to marketing a product is pretty direct and total.  But then, we think a lot of things should be preempted.

In the meantime, if anybody knows of additional recall cases, please let us know. In the meantime we hope that the generic manufacturers will repulse this latest attempt to create an extremely dangerous and overreaching cause of action out of nothing.

Rehearing Sought In Mensing

The plaintiffs in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011) (not sure why it’s all-caps, but that’s the way the Supreme Court has it), have sought reargument. Here’s a copy of their petition.


Any Supreme Court rehearing petition is a long shot, but in this case, we’d have to say it’s worse than that.  Mensing is a clear case of “be careful what you ask for, you just might get it.”

That’s, of course, because of the grounds asserted for rehearing.  Plaintiffs now claim that the Court overlooked another supposedly “alternative” theory of liability, specifically:

[T]he Petitioner generic drug companies could have “independently” complied with both state and federal law simply by suspending sales of generic metoclopramide with warnings that they knew or should have known were inadequate.

Mensing rehearing petition at 1.

Okay…. There are just two slight problems with this “take off the market” theory.

First, it doesn’t exist under state law.  A “take off the market” theory is merely a reworded variant of a “duty to recall” claim that has been rejected by the Third Restatement and by state law.  The Restatement states flatly that there’s no common-law duty beyond non-negligently complying with a government-ordered or privately-undertaken product recall.  Restatement (Third) of Torts, Products Liability §11 (1998).  There’s no common-law duty to initiate a product recall in the first instance.  In short, state product liability law is not in the business of banning products (whether or not federally approved) from the market.

As for the case law rejecting this sort of theory, we addressed that in our “Total Recall” post that cites law from twenty-eight states.  Since that post, we’ve added Lance v. Wyeth, 4 A.3d 160 (Pa. Super 2010), and Bartlett v. Mutual Pharmaceutical Co., 2010 WL 3092649 (D.N.H. Aug. 2, 2010), to the list.  Notably, one of the states explicitly rejecting duty to recall is plaintiff Mensing’s home state of Minnesota.  See Kladivo v. Sportsstuff, Inc., 2008 WL 4933951, at *5 (D. Minn. Sept. 2, 2008); Hammes v. Yamaha Motor Corp. U.S.A., Inc., 2006 WL 1195907, at *11 (D. Minn. May 4, 2006); Berczyk v. Emerson Tool Co., 291 F. Supp.2d 1004, 1006 (D. Minn. 2003); McDaniel v. Bieffe USA, Inc., 35 F. Supp.2d 735, 743 (D. Minn. 1999).  The issue never comes up in plaintiff Demahy’s home state of Louisiana, because a statute delineates the only acceptable product liability claims – and duty to recall/not to sell at all sure ain’t one of them.

So the first problem with the plaintiff’s latest theory in Mensing is that it doesn’t exist at all under state law.  In terms of preemption, that also means that it can’t possibly serve as the basis of a “parallel” violation claim (Petition at 3) either, since no “parallel” state law claim actually exists.

The second problem with the Mensing petition is that, since the original Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), case over a decade and a half ago, we can’t think of a better candidate for preemption – whether asserted against any drug or device maker, branded, generic, or otherwise – than a claim that state law can effectively order a FDA-approved product (or any federally approved product, for that matter) off the market.  Such a claim presents an absolute and total conflict of the “yes/no” variety.  That is, where a federal agency such as the FDA reviews a product and tells its manufacturer, “yes, you can market this,” it’s a pretty raw conflict for state common law to tell the same manufacturer of the same product “you should not have marketed this product in our state.”

It’s hard to come up with a more direct – and thus more conflict preempted – collision between federal and state law.  Forget any need for “independent” FDA pre-approval of this or that warning change.  Indeed, forget labeling altogether.  A “take off the market” claim presents far deeper concerns.  Such a claim strikes at the heart of the federal mission that Congress delegated to the FDA, which is to decide what drugs (and other regulated products) should be available to the public in this country.

In that vein, we note that the Mensing petition (at 2) mentions that the court of appeals in Mensing made a thoughtless comment suggesting that the defendant could simply take its FDA-approved drug off the market in response to state tort suits.  We also note that even the four Supreme Court dissenters in Mensing, who rejected any and all preemption, were unwilling to find that a “take off the market” claim survived preemption:

In its decision below, the Eighth Circuit suggested that the Manufacturers could not show impossibility because federal law merely permitted them to sell generic drugs; it did not require them to do so.  [citing Mensing]  Respondents have not advanced this argument, and I find it unnecessary to consider.

131 S.Ct. 2567, 2587 n.8 (dissenting opinion). We strongly doubt that (having already pointed out plaintiffs’ waiver) all four of the dissenters would be willing to allow state-law litigants to argue that federally-approved products should not be sold at all.  And we doubt even more that any of the majority that found plaintiffs’ other theories preempted would allow that a “take off the market” theory to survive.

We don’t expect the Mensing petition to be granted, as the theory plaintiffs now advance is even more extreme than it is tardy.  That’s why it doesn’t exist, and why, if it did, it would be preempted.